Status:
COMPLETED
MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder
Lead Sponsor:
MEDRx USA, Inc.
Conditions:
Acute Tendonitis
Bursitis
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonit...
Eligibility Criteria
Inclusion
- Main
- Subject is 14 years of age or older (with assent according to state law).
- Females of child bearing potential must have a negative pregnancy test.
- Subject has a diagnosis of acute tendonitis or bursitis of one shoulder with the onset of the current episode 5 days and ≤ 21 days preceding the screening visit. Diagnosis is indicated by a positive Hawkins Test and Neer Test, both resulting in pain with motion and the existence of shoulder impingement related to tendonitis or bursitis.
- Subject has a Current Pain Intensity rated prior to study entry ≥ 5 but ≤ 8 on a Numeric Pain Rating Scale (NPRS) (11 point; range 0 to 10; anchors to be "none" and "severe").
- Main
Exclusion
- Subject has a suspected tear in the rotator cuff, calcific tendonitis.
- Standard of Care (SOC) diagnosis with an AP and lateral x-ray, adhesive capsulitis, shoulder fractures, bilateral tendonitis or bursitis of the shoulders; or orthopedic surgical treatment is required.
- Subject has a positive Drop Arm Test indicative of a suspected tear; a positive O'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test which would be indicative of glenohumeral instability.
- Subject had a previous episode of shoulder pain in the same area within two months.
- Subject received passive physical therapy treatments (e.g., deep heat or ultrasound) for the tendonitis/bursitis for the target shoulder within the past 24 hours; requires continued use of an immobilization device for treatment of the current episode of tendonitis or bursitis or use of iontophoresis.
- Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) less than 3 half-lives before the baseline assessments; ibuprofen is permitted prior to baseline as long as it is not within 6 hours of the baseline assessment.
- Subject has used any form of opioid within 24 hours of study entry or use of opioids for 5 or more consecutive days within the 30 days preceding enrollment.
- Subject has received systemic corticosteroids in the 30 days preceding the screening visit.
- Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants.
- Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60 days.
- Subject has a history or physical assessment finding of clinically significant.
- GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart, or other vital organ disease as determined by the study investigator/physician.
- Subject has a history or physical assessment finding that is not compatible with safe participation in the study.
- Subject has a pain or medical problem that in the investigator's opinion may interfere with pain measurement of the target joint.
- Subject has active skin lesions or disease at the intended site of application of the study medication.
- Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
- Subject has a history of prior failed treatment with topical NSAIDs.
- Subject has a history of drug or alcohol abuse.
- Subject received an investigational drug within a period of 30 days prior to receiving study medication.
- Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.
- Subject is on workman's compensation or has pending legal hearings.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01161615
Start Date
July 1 2010
End Date
June 1 2011
Last Update
January 17 2018
Active Locations (35)
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1
Chandler, Arizona, United States, 85224
2
Phoenix, Arizona, United States, 85050
3
North Little Rock, Arkansas, United States, 72114
4
Chico, California, United States, 95929